Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias

Terminated

• Conditions: Pathological Processes
• Interventions: Procedure: Normal Controls; Procedure: Recurrent Hernia

• Registration Number: NCT00527670
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

The aim of this study is to compare collagen composition in the skin and fascia of patients with recurrent or incisional hernias versus normal controls. We will identify potential genes responsible for genetic alterations in collagen deposition by using gene chip analysis of the tissue obtained and comparing the hernia group versus controls. The ultimate goal of this study is to identify target genes which may help us eventually predict which patients are at risk for developing post-operative hernias.

Detailed Description

This is a prospective, case control pilot study with the aim of identifying potential genetic influences on recurrent hernia formation. Patients with recurrent abdominal hernias will be compared with normal control subjects. The study endpoints will compare tissue collagen I/III ratios between the groups. It will also use gene chip technology to identify potential differences in gene expression between the two groups, followed by confirmation of the differential expression using RT-PCR.

Patients will be enrolled from the surgical clinic population. If they consent to the study, both the hernia group and the control group will have 0.5 x 0.5 x 0.1 cm3 pieces of skin and fascia collected at the time of their surgery. A small piece of tissue will be used for immunofluorescene to study collagen I/III ratios. RNA will be extracted from the rest of the tissue for the genetic studies.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-05
• Last Update Posted: 2016-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Hernia Group: Diagnosis of ventral or incisional hernia.
• Control Group: appendicitis, symptomatic cholelithiasis or cholecystitis, adrenal disease necessitating adrenalectomy.
• Scheduled for an appropriate laparoscopic repair of above diagnosis.
• Females only: Not pregnant.

Exclusion Criteria

• Steroid use
• Severe COPD or pulmonary disorders
• History of a connective tissue disorder
• Presentation for surgery with a diagnosis other than those listed above in inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal Controls	Normal Controls	Healthy patients undergoing laparoscopic surgery for cholelithiasis, appendicitis, and adrenalectomy.
Recurrent Hernia	Recurrent Hernia	Patients presenting for laparoscopic repair of ventral or incisional hernias.

Trial Locations

Locations (1)

University of Missouri Hospital and Clinics; 🇺🇸 Columbia, Missouri, United States